Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-185-8 | CAS number: 104-21-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Oral: The acute oral toxicity study with 2000 mg/kg bw of the test substance caused no mortality in rats and therefore a LD0 of 2000 mg/kg bw and LD50 cut off >=5000 mg/kg bw were derived.
Dermal: The acute dermal LD50 was determined to be greater than 2000 mg/kg bw in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-10-27 to 2015-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 181.5−198.2 g
- Fasting period before study: overnight (16 h)
- Housing: Stainless wire mesh cage, 260W×350D×210H (mm), one animal/cage (during the study)
- Diet: ad libitum, Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), Lot: 2918C-051215MA, Harlan Laboratories, Inc., U.S.A.
- Water: ad libitum, public tap water in Cheongju-si was filtered and irradiated by ultraviolet light
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2−23.4
- Humidity (%): 48.6−55.2
- Air changes (per hr): 10−15, fresh, filtered
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle: 5 mL/kg
- Lot/batch no.: MKBS6944V
CLASS METHOD
- Rationale for the selection of the starting dose: Due to expected low toxicity of the test substance and based on the information supplied by the sponsor, 2000 mg/kg was selected as the starting dose for this study. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6, all females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs at 30 minutes after dosing and at 1, 2, 4 and 6 h after dosing on Day 0 and once daily thereafter for 14 days (Day 1 to Day 14). The body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Statistical analysis was not performed. Mean scores and values are determined.
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no effects on the mortality.
- Clinical signs:
- Decrease of fecal volume was evident in one animal at 2000 mg/kg on Day 1 after dosing, and then it normalized on Day 2 after dosing. Therefore, it was considered to be a test substance-related temporary change.
- Body weight:
- A tendency to suppressed body weight gain was evident in all animals at 2000 mg/kg on Day 1 after dosing. Then, these animals returned to be normal on Day 3. These changes were considered to be test substance-related effects.
- Gross pathology:
- No grossly visible evidence of morphological abnormalities was evident in any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity study with 2000 mg/kg bw of the test substance caused no mortality in rats and therefore a LD0 of 2000 mg/kg bw and LD50 cut off >=5000 mg/kg bw were derived.
- Executive summary:
In an orale acute toxicity study, six fasted Sprague-Dawley female rats, divided into two groups, were orally exposed once with the test substance at a concentration level of 2000 mg/kg bw and were observed for a period of 14 days (OECD 423). No deaths and abnormalities at necropsy were observed. Decrease of fecal volume was evident in one animal on Day 1, it normalized on Day 2. A tendency to suppressed body weight gain was evident in all animals at on Day 1. The body weight gain returned to be normal on Day 3 for all animals. The LD0 value of the test material was established to be 2000 mg/kg bw. The LD50cut off value of the test material was estimated to be greater than 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP-conform study according to OECD guideline.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-11-10 to 2015-12-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 276.9 −294.0 g, female: 224.9 −246.8 g
- Housing: Stainless wire mesh cage, 260W×350D×210H (mm), one animal/cage (during the study)
- Diet: ad libitum, Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), Lot: 2918C-062215MA , 2918C-080315MA, Harlan Laboratories, Inc., U.S.A.
- Water: ad libitum, public tap water in Cheongju-si was filtered and irradiated by ultraviolet light
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2−22.6
- Humidity (%): 47.7-57.6
- Air changes (per hr): 10−15, fresh, filtered
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: subscapular dorsal surface of back, 4 cm*5 cm
- Type of wrap if used: lint tape and plastic film, over-wrapped with Soft Cloth Tape with Liner and surgical tape
REMOVAL OF TEST SUBSTANCE
- Washing: absorbent cotton moistened with tepid water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 1.81 mL/kg bw corresponding to 2000 mg/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 1.81 mL/kg bw corresponding to 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1 to Day 14). The body weight was recorded recorded prior to dosing on Day 0 and on Days 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Statistical analysis was performed using SAS Program (version 9.3, SAS Institute Inc., U.S.A.). Body weights were analyzed utilizing Folded-F test for homogeneity of variance (significance level: 0.05). Student t-test was employed on homogeneous data (significance levels: 0.05 and 0.01, two-tailed).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- No clinical abnormalities was observed.
- Body weight:
- No statistical significant difference between control and treatment group was observed.
- Gross pathology:
- No grossly visible findings were evident in any animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 was determined to be greater than 2000 mg/kg bw in rats.
- Executive summary:
An acute dermal toxicity study according to OECD 402 was conducted in rats. Test groups consisted of one dose group at a dose of 2000 mg/kg bw and a control group. Both groups consisted of 5 males and 5 females. All animals were monitored for clinical signs and body weight changes after dosing during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period. All animals survived the duration of the study. No test substance-related effects were evident in clinical signs, body weight data or necropsy findings. Based on the results of this study, the LD50 value of the test substance was considered to be greater than 2000 mg/kg bw in male and female rats under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP-conform study according to OECD guideline.
Additional information
Acute toxicity
Oral:
In an oral acute toxicity study (key study), six fasted Sprague-Dawley female rats, divided into two groups, were orally exposed once with the test substance at a concentration level of 2000 mg/kg bw and were observed for a period of 14 days (OECD 423). No deaths and abnormalities at necropsy were observed. Decrease of fecal volume was evident in one animal on Day 1, it normalized on Day 2. A tendency to suppressed body weight gain was evident in all animals on Day 1. The body weight gain returned to be normal on Day 3 for all animals. The LD0 value of the test material was established to be 2000 mg/kg bw. The LD50cut off value of the test material was estimated to be greater than 5000 mg/kg bw.
Dermal:
An acute dermal toxicity study according to OECD 402 was conducted in rats. Test groups consisted of one dose group at a dose of 2000 mg/kg bw and a control group. Both groups consisted of 5 males and 5 females. All animals were monitored for clinical signs and body weight changes after dosing during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period. All animals survived the duration of the study. No test substance-related effects were evident in clinical signs, body weight data or necropsy findings. Based on the results of this study, the LD50 value of the test substance was considered to be greater than 2000 mg/kg bw in male and female rats under the conditions of this study.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral and dermal route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.